Antares Pharma, Inc. (NASDAQ: ATRS) (“the Company”), a
pharmaceutical technology company, today reported operating and
financial results for the second quarter ended June 30, 2020 with
record second quarter revenue of $32.4 million and net income of
$2.2 million, or earnings per share of $0.01. The Company
also reported record six-month year-to-date revenue of $65.5
million, a 27% increase versus the first six months of 2019.
“I am very proud of the Antares team for
delivering strong quarterly results while navigating the challenges
presented by the COVID-19 pandemic. We remain committed to
protecting the health and safety of our employees, patients, and
health care providers while effectively operating our business to
meet the needs of our partners and patients during this
unprecedented time. The Company’s second quarter revenue of $32.4
million, which represents 14% year-over-year growth, was primarily
driven by our proprietary product XYOSTED. The second quarter had
the highest number of XYOSTED prescriptions to date, and we believe
this is the result of the tremendous execution by our commercial
team and highlights the demand for an easy to use, painless at-home
testosterone injection option given limited physician and patient
access at this time. Revenue from proprietary products, XYOSTED and
OTREXUP, our highest margin products, grew 65% in the quarter
versus the same period last year and now represent 60% of our total
product revenue,” said Robert F. Apple, President and Chief
Executive Officer of the Company.
“We also continued to advance our product
pipeline with the recently launched Teriparatide Injection
(“teriparatide”) by Teva, the generic version of Eli Lilly’s brand
Forsteo, in Canada and certain countries in Europe. According to
Teva, the initial launch of teriparatide, which utilizes our
multi-dose pen technology, will expand into other European
countries later this year. Additionally, we look forward to a
potential U.S. approval of a generic Forteo later this year.
Finally, while the pandemic continues to pose some uncertainty for
the second half of the year, we are encouraged by the growth of our
business and the opportunities ahead, and therefore we have
reinstated our revenue guidance for the full year,” Mr. Apple
concluded.
Second Quarter 2020 and Recent
Highlights
- Reported second quarter total 2020 revenue of $32.4 million, an
increase of 14% compared to the same period last year.
Proprietary product revenue increased 65% to $14.8 million as
compared to $9.0 million in the second quarter of 2019.
Reported second quarter 2020 earnings per share of $0.01 as
compared to a $0.01 loss per share reported in the comparable
period last year.
- According to Symphony Health Solutions, XYOSTED® total
prescriptions increased 11% sequentially versus the first quarter
of 2020. Since the product launched, more than one hundred
thirty-two thousand prescriptions of XYOSTED® have been written by
almost six thousand different physicians.
- Announced the first commercial product using Antares Pharma’s
multi-dose pen platform was launched by the Company’s development
partner Teva Pharmaceutical Industries, Ltd. Teriparatide
Injection, the generic version of Eli Lilly’s brand product
Forsteo® was launched in Austria, Croatia, Denmark, Hungary,
Ireland, The Netherlands, Portugal, Sweden, Switzerland, The United
Kingdom as well as Canada and Israel. Teva has indicated they
expect to launch in other European countries later this
year.
- Announced an exclusive distribution agreement with Lunatus
Global Medical Supplies to register, promote and distribute
XYOSTED® in Saudi Arabia and the United Arab Emirates.
- Cash, cash equivalents and short-term investments increased to
$51.6 million at June 30, 2020, compared to $45.7 million at
December 31, 2019.
Second Quarter 2020 Financial
Results
Total revenue generated from product sales,
development activities and royalties was $32.4 million for the
three months ended June 30, 2020, a 14% increase compared to $28.4
million in the same period in 2019. For the six months ended
June 30, 2020, total revenue was $65.5 million, a 27% increase from
$51.7 million for the comparable period in 2019.
Product sales were $24.7 million for the three
months ended June 30, 2020, a 20% increase compared to $20.6
million for the same period in 2019. For the six-month period
ended June 30, 2020, product sales were $51.8 million, a 33%
increase from $38.9 million in the comparable period in 2019.
Sales of our proprietary products XYOSTED® and
OTREXUP® generated revenue of $14.8 million and $27.4 million for
the three and six months ended June 30, 2020, respectively, as
compared to $9.0 million and $13.8 million for the three and six
months ended June 30, 2019, respectively. The 65% and 99%
increase in proprietary product sales for the three and six months
ended June 30, 2020 respectively, compared to the three and
six months ended June 30, 2019 were principally attributable
to sales of XYOSTED®.
Partnered device sales were $9.8 million and
$11.6 million for the three months ended June 30, 2020 and
2019, respectively, and $24.4 million and $25.2 million for the six
months ended June 30, 2020 and 2019, respectively. The decrease in
sales of partnered products for the three and six months ended
June 30, 2020 as compared to the same period in 2019 is
primarily attributable to a decrease in sales of needle-free
devices to Ferring, and a decrease in sales of Sumatriptan
Injection USP and teriparatide devices to Teva. Antares
previously announced the divestiture of the needle-free device to
Ferring and shipment of pre-launch quantities of teriparatide
devices to Teva during the first two quarters of 2019.
Licensing and development revenue was $2.7
million and $4.4 million for the three and six-month periods ended
June 30, 2020, respectively, compared to $2.2 million and $3.2
million for the comparable periods in 2019, respectively.
Licensing and development revenue for the three and six-
month periods was primarily from the Pfizer rescue pen and the
Idorsia selatogrel pen development programs.
Royalty revenue was $5.0 million for the three
months ended June 30, 2020 compared to $5.6 million for the same
period in 2019. For the six-month period ended June 30, 2020,
royalty revenue was $9.3 million, compared to $9.6 million for the
same period in 2019. The decrease in royalty revenue for the
three and six-month periods were primarily attributable to a
decline in royalties recognized from AMAG on their net sales of the
Makena® subcutaneous auto injector.
Operating expenses were $16.9 million for the
second quarter of 2020 compared to $17.6 million in the comparable
period of 2019. Total operating expenses for the six months
ended June 30, 2020 were $36.3 million as compared to $34.9 million
for the comparable period in 2019. The increase in operating
expenses for the six-month period of 2020 as compared to the same
period in 2019 was primarily attributable to increased head count
as well as increased non-cash incentive compensation expense.
Net income was $2.2 million, or $0.01 per share
for the second quarter of 2020, compared to a net loss of $2.2
million, or $0.01 per share in the same period in 2019. Net
loss was $0.2 million, or $0.00 per share for the six months ended
June 30, 2020 compared to a net loss of $7.8 million, or $0.05 per
share in the comparable period of 2019.
At June 30, 2020, cash, cash equivalents and
short-term investments were $51.6 million compared to $45.7 million
at December 31, 2019.
2020 Financial Guidance
The Company today reinstated 2020 full-year
revenue guidance in a range of $135 to $155 million, which
represents a 9% to 25% year-over-year growth rate. Given the
unprecedented and unpredictable environment created by the COVID-19
pandemic, we reserve the right to revisit revenue guidance at some
future point in time.
Webcast and Conference Call
Information
Antares executives will provide a Company update
and review second quarter 2020 financial results via webcast and
conference call today, August 6, 2020, at 8:30 a.m. ET (Eastern
Time). The webcast of the conference call, which will include
a slide presentation, can be accessed through the link
located on the “For Investors” section of the Company’s
website (www.antarespharma.com) under “Webcasts &
Presentations”. Alternatively, callers may participate in the
audio portion of the conference call by dialing toll free
1-800-353-6461, or 1-334-323-0501. Callers should reference
the Antares Pharma conference call or conference identification
code 5888699. Callers can access the slide presentation on
the “For Investors” section of the Company’s website under
“Webcasts & Presentations”.
A telephone replay of the conference call will
be available from 11:30 a.m. ET on Thursday, August 6, 2020 through
11:30 a.m. ET on Saturday, September 5, 2020. To access the
replay, callers should dial 1-888-203-1112 or 1-719-457-0820 and
enter passcode 5888699.
About Antares Pharma
Antares Pharma, Inc. is a pharmaceutical
technology company focused primarily on the development and
commercialization of self-administered injectable pharmaceutical
products using advanced drug delivery auto injector
technology. The Company has a portfolio of proprietary and
partnered commercial products with several product candidates in
various stages of development, as well as significant strategic
alliances with industry leading pharmaceutical companies including
Teva Pharmaceutical Industries, Ltd. (Teva), AMAG Pharmaceuticals,
Inc. (AMAG), Pfizer Inc. (Pfizer) and Idorsia Pharmaceuticals Ltd.
(Idorsia). Antares Pharma’s FDA approved products include
XYOSTED® (testosterone enanthate) injection, OTREXUP®
(methotrexate) injection for subcutaneous use and Sumatriptan
Injection USP, which is distributed by Teva.
SAFE HARBOR STATEMENT UNDER THE PRIVATE
SECURITIES LITIGATION REFORM ACT OF 1995
This press release contains
forward-looking statements within the meaning of the safe harbor
provisions of the Private Securities Litigation Reform Act of
1995. Forward-looking statements are subject to certain risks
and uncertainties that can cause actual results to differ
materially from those described. Factors that may cause such
differences include, but are not limited to: Teva’s successful
commercialization of teriparatide injection in Europe and future
revenue from the same; the uncertainty regarding the duration,
scope and severity of the COVID-19 pandemic and the mitigation
measures and other restrictions implemented in response to the same
and the impact on reinstated 2020 full-year revenue guidance,
demand for our products, new patients and prescriptions, future
revenue, product supply, and our overall business, operating
results and financial condition; market acceptance, adequate
reimbursement coverage and commercial success of XYOSTED® and
future revenue from the same; successful development including the
timing and results of the clinical bridging and Phase 3 clinical
trial of the drug device combination product for Selatogrel with
Idorsia Pharmaceuticals and FDA and global regulatory approvals and
future revenue from the same; market acceptance of Teva’s generic
epinephrine auto-injector product and future revenue from the same;
the ability of Lunatus to obtain regulatory approvals for
XYOSTED® in Saudi Arabia and UAE and successfully
commercialize the product and future revenue from the same; our
expectations regarding whether the FDA will pursue withdrawal of
approval for AMAG Pharmaceuticals Inc.’s Makena® subcutaneous auto
injector following the recent FDA advisory committee meeting
and future prescriptions, market acceptance and
revenue from Makena® subcutaneous auto injector; Teva’s ability to
successfully commercialize VIBEX® Sumatriptan Injection USP and the
amount of revenue from the same; continued growth of prescriptions
and sales of OTREXUP®; the timing and results of the
Company’s or its partners’ research projects or clinical trials of
product candidates in development; actions by the FDA or
other regulatory agencies with respect to the Company’s products or
product candidates of its partners; continued growth in product,
development, licensing and royalty revenue; the Company’s ability
to meet loan extension and interest only payment milestones and the
ability to repay the debt obligation to Hercules Capital; the
Company’s ability to obtain financial and other resources for its
research, development, clinical, and commercial activities and
other statements regarding matters that are not historical facts,
and involve predictions. These statements involve known and unknown
risks, uncertainties and other factors that may cause actual
results, performance, achievements or prospects to be materially
different from any future results, performance, achievements or
prospects expressed in or implied by such forward-looking
statements. In some cases you can identify forward-looking
statements by terminology such as ''may'', ''will'', ''should'',
''would'', ''expect'', ''intend'', ''plan'', ''anticipate'',
''believe'', ''estimate'', ''predict'', ''potential'', ''seem'',
''seek'', ''future'', ''continue'', or ''appear'' or the negative
of these terms or similar expressions, although not all
forward-looking statements contain these identifying words.
Additional information concerning these and other factors that may
cause actual results to differ materially from those anticipated in
the forward-looking statements is contained in the "Risk Factors"
section of the Company's Annual Report on Form 10-K, and in the
Company's other periodic reports and filings with the Securities
and Exchange Commission. The Company cautions investors not
to place undue reliance on the forward-looking statements contained
in this press release. All forward-looking statements are based on
information currently available to the Company on the date hereof,
and the Company undertakes no obligation to revise or update these
forward-looking statements to reflect events or circumstances after
the date of this press release, except as required by
law.
Contact:Jack HowarthVice
President, Corporate
Affairs609-359-3016jhowarth@antarespharma.com
ANTARES PHARMA,
INC.Table 1 - CONSOLIDATED CONDENSED STATEMENTS OF
OPERATIONS(amounts in thousands except per share
amounts)(unaudited)
|
|
Three Months Ended |
|
|
|
|
|
|
Six Months Ended |
|
|
|
|
|
|
|
June 30, |
|
|
Increase |
|
|
June 30, |
|
|
Increase |
|
|
|
2020 |
|
|
2019 |
|
|
(Decrease) |
|
|
2020 |
|
|
2019 |
|
|
(Decrease) |
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product sales |
|
$ |
24,665 |
|
|
$ |
20,620 |
|
|
20% |
|
|
$ |
51,762 |
|
|
$ |
38,920 |
|
|
33% |
|
Licensing and development revenue |
|
|
2,687 |
|
|
|
2,239 |
|
|
20% |
|
|
|
4,442 |
|
|
|
3,154 |
|
|
41% |
|
Royalties |
|
|
5,032 |
|
|
|
5,574 |
|
|
-10% |
|
|
|
9,259 |
|
|
|
9,645 |
|
|
-4% |
|
Total revenue |
|
|
32,384 |
|
|
|
28,433 |
|
|
14% |
|
|
|
65,463 |
|
|
|
51,719 |
|
|
27% |
|
Cost of Revenue |
|
|
12,477 |
|
|
|
12,441 |
|
|
0% |
|
|
|
27,524 |
|
|
|
23,387 |
|
|
18% |
|
Gross profit |
|
|
19,907 |
|
|
|
15,992 |
|
|
24% |
|
|
|
37,939 |
|
|
|
28,332 |
|
|
34% |
|
Research and development |
|
|
2,417 |
|
|
|
2,494 |
|
|
-3% |
|
|
|
5,398 |
|
|
|
4,881 |
|
|
11% |
|
Selling, general and
administrative |
|
|
14,448 |
|
|
|
15,087 |
|
|
-4% |
|
|
|
30,870 |
|
|
|
30,022 |
|
|
3% |
|
Total operating expenses |
|
|
16,865 |
|
|
|
17,581 |
|
|
-4% |
|
|
|
36,268 |
|
|
|
34,903 |
|
|
4% |
|
Operating income (loss) |
|
|
3,042 |
|
|
|
(1,589 |
) |
|
** |
|
|
|
1,671 |
|
|
|
(6,571 |
) |
|
** |
|
Other expense |
|
|
(867 |
) |
|
|
(637 |
) |
|
36% |
|
|
|
(1,852 |
) |
|
|
(1,194 |
) |
|
55% |
|
Net income (loss) |
|
$ |
2,175 |
|
|
$ |
(2,226 |
) |
|
** |
|
|
$ |
(181 |
) |
|
$ |
(7,765 |
) |
|
-98% |
|
Net income (loss) per common
share, basic and diluted |
|
$ |
0.01 |
|
|
$ |
(0.01 |
) |
|
|
|
|
|
$ |
(0.00 |
) |
|
$ |
(0.05 |
) |
|
|
|
|
Weighted average common shares
outstanding: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
165,703 |
|
|
|
162,734 |
|
|
|
|
|
|
|
165,566 |
|
|
|
161,596 |
|
|
|
|
|
Diluted |
|
|
169,228 |
|
|
|
162,734 |
|
|
|
|
|
|
|
165,566 |
|
|
|
161,596 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ANTARES PHARMA,
INC.Table 2 – CONSOLIDATED DETAIL OF REVENUE FROM
PRODUCT SALES(amounts in
thousands)(unaudited)
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2020 |
|
|
2019 |
|
|
2020 |
|
|
2019 |
|
Product sales: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
XYOSTED® |
|
$ |
10,902 |
|
|
$ |
4,623 |
|
|
$ |
19,905 |
|
|
$ |
5,326 |
|
OTREXUP® |
|
|
3,944 |
|
|
|
4,361 |
|
|
|
7,507 |
|
|
|
8,429 |
|
Partnered product sales |
|
|
9,819 |
|
|
|
11,636 |
|
|
|
24,350 |
|
|
|
25,165 |
|
Total product sales |
|
$ |
24,665 |
|
|
$ |
20,620 |
|
|
$ |
51,762 |
|
|
$ |
38,920 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ANTARES PHARMA,
INC.Table 3 – CONSOLIDATED CONDENSED BALANCE
SHEETS(amounts in
thousands)(unaudited)
|
|
June 30, |
|
|
December 31, |
|
|
|
2020 |
|
|
2019 |
|
Assets |
|
|
|
|
|
|
|
|
Cash, cash equivalents and
investments |
|
$ |
51,550 |
|
|
$ |
45,721 |
|
Accounts receivable |
|
|
34,293 |
|
|
|
35,074 |
|
Inventories |
|
|
19,605 |
|
|
|
16,000 |
|
Contract assets |
|
|
7,013 |
|
|
|
8,235 |
|
Equipment, molds, furniture
and fixtures, net |
|
|
19,452 |
|
|
|
15,961 |
|
Right of use assets |
|
|
4,860 |
|
|
|
5,463 |
|
Other assets |
|
|
6,351 |
|
|
|
6,297 |
|
Total Assets |
|
$ |
143,124 |
|
|
$ |
132,751 |
|
|
|
|
|
|
|
|
|
|
Liabilities and Stockholders’ Equity |
|
|
|
|
|
|
|
|
Accounts payable and accrued
expenses |
|
$ |
37,633 |
|
|
$ |
30,677 |
|
Deferred revenue |
|
|
2,341 |
|
|
|
1,738 |
|
Long-term debt and other
liabilities |
|
|
45,821 |
|
|
|
45,836 |
|
Stockholders’ equity |
|
|
57,329 |
|
|
|
54,500 |
|
Total Liabilities and Stockholders’ Equity |
|
$ |
143,124 |
|
|
$ |
132,751 |
|
|
|
|
|
|
|
|
|
|
Antares Pharma (NASDAQ:ATRS)
Historical Stock Chart
From Mar 2024 to Apr 2024
Antares Pharma (NASDAQ:ATRS)
Historical Stock Chart
From Apr 2023 to Apr 2024